MDR Transition: Countdown to compliance


When the European Medical Devices Regulation 2017/745 (MDR) takes effect, it will transform the regulatory system that governs the world’s second-largest medical device market. Manufacturers will have to meet different and, in many regards, more stringent requirements in order to obtain CE Marking and maintain access to the European market. Despite the rapidly approaching start date, many companies are still trying to understand what steps need to be taken to bridge the gap between MDD and MDR compliance. If you need help seeing the big picture, this webinar should help you to grasp your upcoming priorities and anticipate many of the complexities of MDR implementation.

Senior Consultant Ronald Boumans will tackle the issue of the impending MDR transition, focusing on the following topics:

  • New regulations under MDR:
    • The certification grace period; risks and possible mitigations
    • The Unique Device Identifier (UDI) system and labeling challenges
    • The EUDAMED database; implementation and delay ramifications
  • Challenges facing the European Single Market:
    • The evolving impact of Brexit
    • Bilateral treaties with Switzerland
    • The EU-Turkey Customs Union
  • Extra: update regarding the impact of the COVID-19 pandemic on the MDR implementation

ABOUT THE PRESENTER:
Ronald Boumans brings with him 30+ years of experience in the medical device sector. He began in industry as a product designer; imported and distributed medical devices; participated in research into quality of patients’ lives in relation to the use of medical devices in an organization that also worked as a notified body for medical devices; and worked 10+ years as an Inspector for the Dutch Healthcare Inspectorate, the Competent Authority for The Netherlands. Ronald was also involved in the first impact assessments of the MDR/IVDR. Since joining Emergo by UL in 2013, Ronald has worked on 100+ projects, including Technical Files, Clinical Evaluation Reports, helping “orphaned” manufacturers maintain CE marking after their Notified Bodies left the market, and gap assessments between the MDD and MDR. He is member in several European Commission working groups, mainly supporting the development of Eudamed.

This webinar was recorded on April 9, 2020.